Archive for MHRA Updates
Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23
Source: MHRA / Gov.uk 18.6.24 Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate)...
Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets, EL (24)A/22
Source: MHRA / Gov.uk 17.6.24 Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg...
Class 4 Medicines Defect Information: Dawa Limited, Paracetamol 500mg, 1000mg Film-Coated Tablets, EL (24)A/21
Source: MHRA/Gov.uk 10.6.24 Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL). MDR number MDR 312-04/24...
Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension, EL(24)A/20
Source: MHRA/Gov.uk 7.6.24 Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the...
Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19
Source: MHRA / Gov.uk 5.6.24 Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after...
Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18
Source: MHRA/ Gov.uk 3.6.24 Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table. MDR number MDR...
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus), EL (24)A/17
Source: MHRA / Gov.uk 22.5.24 Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS. MDR...
Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15
Source: MHRA / Gov.uk 22.5.24 The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the...
Class 4 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15
Source: MHRA / Gov.uk 15.5.24 Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by...
Class 3 Medicines Recall: Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection
Source: MHRA /Gov.uk 23.4.24 (Cheplapharm – Canadian Livery), EL(24)A/14: Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure. MDR number MDR 191-04/24 Company...
Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device
Source: MHRA/Gov.uk 23.4.24 Risk of Early Revision, DSI/2024/005 The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with...
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12 Source: MHRA / Gov.uk 10.4.24 Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg...
